The OBR Blog

Sales of oral cancer drugs have more than tripled to $20.6 billion in five years and now account for 25.9% of total global oncology drug sales.1 Despite early concerns that reliance on buy-and-bill revenues might dampen use of oral anticancer drugs, oncologists recognize and act on the clinical benefit of these oral drugs. However, it remains unclear whether prescribing and patient use of oral drugs has been optimized.

A 2012 Kantar Health survey of 150 oncologists showed that 48% of oncologists would be more likely to prescribe an oral drug over an IV drug assuming clinical equivalence.2 Although this percentage is up from 40% two years ago, drug affordability continues to challenge physician prescribing, prescription fulfillment, and patient compliance.

The issue of affordability may become even more acute in 2014, when the individual mandate goes into effect, requiring certain individuals to purchase health insurance or be subject to an additional tax. Using healthcare reform in Massachusetts as a proxy for what might happen with national health reform, the Affordable Care Act (ACA) may simply replace uninsured patients with underinsured patients. Although cost share for drugs at the point of service has generally decreased in Massachusetts, premiums and deductibles are on the rise and are front-loading costs such that patients may not be able to afford the care that would lead to a prescription.3-5 In addition, many patients who otherwise would have received free care face cost sharing for their drugs in addition to potential premiums and deductibles.3-5 As a result, a growing share of Massachusetts residents spend a larger percentage of their incomes on total healthcare costs, and the number of residents facing medical debt and bankruptcy has not declined.3

Cost sharing for oral cancer drugs is particularly challenging given frequent high prices and benefit designs that often favor office-administered drugs. Consequently, treatment abandonment rates for oral anticancer drugs are high across both Medicare beneficiaries and commercial plan members. In a study involving 1,737 Medicare beneficiaries and 8,771 commercially insured patients, approximately 25% of patients who were prescribed an oral cancer drug with an out-of-pocket (OOP) expense exceeding $500 (n=1,727) abandoned therapy on the initial claim versus 6.4% of patients with an OOP cost of $100 or less (n=7,638). Insurance status contributed to likelihood to abandon treatment. Sixteen percent of Medicare beneficiaries’ claims were abandoned versus 9% of commercial claims (P<0.05).6

Efforts to close the Part D coverage gap will do little to help in cancer. Many oral cancer drugs cost enough to move patients through the initial coverage period with the first fill, assuming a patient can afford the coinsurance for a high-cost prescription. Even the 5% cost-share level once in catastrophic coverage may be too high for many seniors, who are often on fixed incomes. The OOP “relief” associated with catastrophic coverage only lasts through the end of the calendar year, at which time beneficiaries must pay their way back to catastrophic coverage.7

Oral parity laws also seek to mitigate disparities in affordability that might influence treatment selection. Many patients are not subject to any cost sharing for their injectable medications, whereas nearly all oral drugs are subject to cost sharing. Since 2007, 17 states and the District of Columbia have enacted oral parity legislation that seeks to ensure that health insurers cover oral anticancer drugs no less favorably than IV chemotherapy. Kantar Health research suggests that there is room to shift costs to patients to compensate for any relief provided by oral parity legislation. Over time, it seems likely that orals will be subject to coinsurance more frequently as this (a) aligns better with IV coverage and (b) would arguably remain within the spirit of parity.

A rise in the number and degree of underinsured patients may require that manufacturers revisit the structure of their free drug and co-pay assistance programs. A question for the lawyers is whether there is a point at which an “underinsured” patient can reasonably be reclassified as “uninsured.”